Page 7 of Attachment C 
The nutrient lines and feed tanks are steril i?ab le , but validation 
of sterilization effectiveness in this system is not conducted. 
Exhaust gas systems are visually checked when cleaned. Millipore fil- 
ter air sampling techniques will be used to evaluate performance of 
these systems. 
All biological safety cabinets receive scheduled performance testing 
and certification. Autoclaves are monitored by recording charts to 
document performance. 
Centrifuge equipment and the Martin Gaulin (French) press receive 
periodic maintenance checks. 
Work Practices 
Specific guidelines for safe work practices are being drafted by the 
safety committee. Good laboratory technique and safe work practices 
are now left to the individuals' experience and the direction of im- 
mediate supervisor. 
Operators of the fermentation systems are trained in the use of the 
equipment, the process methods, and safety precautions. Operators 
are required to use check lists for starting, running, and finishing 
each batch. Emergency procedures are outlined on these check lists. 
Evidence of eating and drinking in laboratory areas was noticed dur- 
ing the facility tour. Laboratory coats and gloves were not consis- 
tantly used by the employees as several employees were observed work- 
ing without laboratory coats. The dual function design of the pro- 
duction area (P-3 or Pl-LS) could conceivably cause work practice 
problems. If this area is designed to function as a P-3 level contain- 
ment laboratory then actual practices and procedures for controlled 
access should be followed. Unrestricted traffic flow to the 600-liter 
fermentor should be discouraged unless distinct procedures are de- 
vised to maintain the integrity of use as a P-3 facility or a pro- 
duction Pl-LS area. 
The company does not have a set safety policy or procedure outlined 
for maintenance performed in laboratories or on fermentation systems. 
Cleaning of the laboratories and the production area is conducted by 
the employees in these areas. Formaldehyde is used to sanitize the 
surfaces in the production room. Paraformaldehyde is vaporized on a 
hot plate to fill the room with formaldehyde vapor. Personnel per- 
forming this operation use a full face protective mask with a re- 
placeable organic vapor cartridge. 
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